Translation of Pritikin Program to the Community

NCT ID: NCT03929198

Last Updated: 2019-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2018-12-01

Brief Summary

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The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.

Detailed Description

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Conditions

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Metabolic Syndrome Obesity Weight Loss Hypertension Hypercholesterolemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.

Group Type EXPERIMENTAL

Healthy Lifestyle

Intervention Type OTHER

6 week Diet, Exercise training, Behavioral modification

Control

This group did not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Healthy Lifestyle

6 week Diet, Exercise training, Behavioral modification

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:

* Triglycerides \> 150 mg/dL OR HDL \<50 in females, \<40 mg/dL in males
* Systolic blood pressure ≥130 mmHg OR diastolic blood pressure ≥80 mmHg (or on hypertension medication)
* HbA1c ≥5.7% or higher
* No diagnosis or treatment for cancer in the past year
* No diagnosis of mild cognitive impairment or dementia in the past year
* Ability to perform daily exercise, including aerobic activity and resistance exercise
* Non-smoker in the past year

Exclusion Criteria

* Positive exercise stress test
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pritikin Longevity Center

UNKNOWN

Sponsor Role collaborator

Wellmont Health System

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1204508

Identifier Type: -

Identifier Source: org_study_id

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